Senior Specialist Regulatory Operations and System Support

1100 Mylan Pharmaceuticals Inc.; Lisboa; Presencial; EUR 42 000 - 62 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Career progression

Work-life balance

Bonus scheme

Health insurance

Pension

Resumo da oferta

Viatris is seeking a Senior Specialist Regulatory Operations and System Support in Lisbon, Portugal. You will coordinate regulatory documentation and XEVMPD/IDMP submissions, liaise with central teams and local affiliates, and drive efficiency across regulatory systems projects under the project lead.

Key duties include data maintenance, responding to health authority queries, and coordinating with MA Coordinators to ensure timely actions.

Qualificações

• Bachelor's degree in a relevant discipline with 2–4 years of experience
• Strong knowledge of EU regulations including Article 57(2), SPOR and IDMP
• Proven expertise in xEVMPD data submissions and related systems
• Experience with Regulatory Information Management Systems (RIMS)
• Proficiency with Document Management Systems (DMS) and tools incl. Adobe Acrobat and MS Office
• Experience engaging with health authorities and external stakeholders
• Ability to work collaboratively across functions and manage time effectively
• Numerical proficiency with percentages, ratios, and rates

Responsabilidades

• Maintain xEVMPD (Article 57) data using XEVMPD software, ensuring data quality and timely submissions
• Respond to EMA and health authority queries regarding xEVMPD/IDMP data
• Provide registration tracking input per regulatory requirements
• Coordinate with MA Coordinators and third parties to complete actions on time
• Support XEVMPD system administration, including user management and updates
• Reconcile xEVMPD/IDMP data with affiliates as required
• Monitor regulatory updates and implement into systems and processes
• Manage SPOR PMS data submissions and maintain product portfolio

Conhecimentos

Bachelor's degree

EU regulation knowledge

xEVMPD submissions

RIMS

DMS and MS Office

Stakeholder engagement

Time management

Adapt to new tech

Numerical skills

Regulatory coordination

Formação académica

Bachelor's degree in a relevant discipline

Ferramentas

Adobe Acrobat

Microsoft Office Suite

RIMS

Descrição da oferta de emprego

Mylan, Lda. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Senior Specialist Regulatory Operations and System Support will support the coordination and management of regulatory documentation and XEVMPD/IDMP submissions to health authorities. Working closely with the central organisation and local affiliates, the role involves tracking registration activities, managing submission status reporting, and ensuring both internal business needs and regulatory authority requirements are met. The successful candidate will also contribute to regulatory systems projects aimed at driving efficiency and effectiveness, while supporting broader project management activities under the direction of the project lead.

• Maintain xEVMPD (Article 57) data utilising XEVMPD software, ensuring data quality and compliance with submission timelines when submitting to Health Authorities.
• Respond to EMA and other Health Authority queries relating to xEVMPD/IDMP data in a timely and accurate manner.
• Provide registration tracking input in line with external and internal regulatory requirements and processes.
• Coordinate regular communication with MA Coordinators and/or third parties to ensure outstanding actions are completed on time and in accordance with regulatory requirements.
• Support XEVMPD system administration, including user management and system updates.
• Perform reconciliation of xEVMPD/IDMP data with affiliates as required.
• Monitor regulatory requirement updates and contribute to their implementation into relevant systems and processes.
• Manage SPOR PMS data submissions and maintain the existing product portfolio within the system.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Minimum of a Bachelor's degree (or equivalent) in a relevant discipline, with 2–4 years of relevant experience; a combination of education and experience will be considered.
• Strong knowledge of EU regulations, specifically relating to Article 57(2), SPOR, and IDMP.
• Proven expertise in xEVMPD data submissions, associated systems, and regulatory requirements.
• Experience working with Regulatory Information Management Systems (RIMS).
• Proficiency with Document Management Systems (DMS) and tools including Adobe Acrobat and the Microsoft Office Suite.
• Experience engaging with health authorities and stakeholders outside of own functional area.
• Demonstrated ability to work collaboratively as part of a team across multiple functions and projects.
• Strong time management skills with the ability to prioritise and deliver within defined timelines.
• Ability to quickly learn and adapt to new technologies and systems.
• Proficient in numerical tasks including the calculation of percentages, ratios, and rates.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.